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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceINTERSTIM THERAPY FOR URINARY CONTROL
Generic NameStimulator, electrical, implantable, for incontinence
Regulation Number876.5270
ApplicantMEDTRONIC NEUROMODULATION
7000 CENTRAL AVENUE, N.E.
MINNEAPOLIS, MN 55432
PMA NumberP970004
Supplement NumberS024
Date Received03/07/2003
Decision Date04/01/2003
Product Code EZW 
Advisory Committee Gastroenterology/Urology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL TO LIMIT USE OF THE MODEL 8870 APPLICATION CARD TO ONLY THE INTERSTIM AND ENTERRA APPLICATIONS BY MODIFYING THE DESKTOP SOFTWARE, TO REMOVE THE MODEL 8529 MAGNET USED WITH THE SYNCHROMED DRUG PUMP APPLICATION FROM THE PROGRAMMING UNIT, AND TO MODIFY THE LABELING TO REFLECT THESE CHANGES.
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